Dialysis catheter anchoring system

ABSTRACT

An anchoring system for securing a dialysis catheter to a patient comprises an anchor pad and a retainer. The anchor pad is attached to the skin of the patient by an adhesive layer on one side of the pad. The retainer is disposed upon the surface of the anchor pad opposite the adhesive layer and includes a base and a cover and a adhesive spot. A groove upon the base is arranged to receive a Y-site portion of a dialysis catheter where the lumens merge distal to the insertion site. A post also protrudes from the base to the cover at a position which will be disposed between the two distal branches of the dialysis catheter. The cover closes over the base, securing the Y-site between the groove and the post. Closing the cover also places at least a portion of the catheter in contact with the adhesive spot. This contact between the retainer, adhesive spot and catheter thereby inhibits inadvertent motion of the catheter upon the patient. A latch mechanism is disposed upon the retainer to maintain the cover in a closed position over the Y-site of the catheter on the base.

RELATED CASES

[0001] This application is a continuation of copending application Ser.No. 09/630,582, filed Aug. 3, 2000 entitled “DIALYSIS CATHETER ANCHORINGSYSTEM”, the entirety of which is hereby incorporated by referenceherein.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates to an anchoring system for securing amedical article to a patient. More specifically, this invention relatesto an anchoring system which retains a dialysis catheter in positionupon a patient without crimping and which may be used with cathetersthat remain in position for extended periods.

[0004] 2. Description of the Related Art

[0005] It is common in kidney dialysis procedures to use a catheterinserted into a major vein near the heart to facilitate the bloodexchange necessary for dialysis. Because dialysis procedures mustgenerally be performed on a regular basis, it is not uncommon for such acatheter to be left in place in between dialysis sessions. This mayreduce the potential risks to the patient associated with having toreintroduce such a catheter prior to each session.

[0006] Other risks, however, arise when leaving such a catheter inposition for extended periods of time. It can be very dangerous for thepatient if the catheter moves substantially in either axial direction.Inadvertent withdrawal of the catheter may lead to bleeding, eitherinternally or externally, and axial advancement of the catheter maypress the catheter tip into the heart or other sensitive internaltissue.

[0007] Furthermore, leaving such a catheter in position on the patienttraditionally requires a taped dressing near the insertion site. The useof such adhesives at the insertion site may retain dirt or othercontaminant particles, potentially leading to infection of the patient.Additionally, removal of taped dressings may itself cause undesiredmotion of the catheter upon the patient.

[0008] An additional drawback to using taped dressings near theinsertion site is that they require periodic changes. The frequent,often daily, removal and reapplication of adhesive tape to the skin ofthe patient can excoriate the skin in the area around the dressing. Thisis especially problematic for dialysis patients, as their skin tends tobe more fragile and sensitive to abrasion due to collagen deficiencycommon to renal conditions. Such repeated applications of tape over thecatheter may also lead to the build up of adhesive residue on the outersurface of the catheter. This residue can result in contaminantsadhering to the catheter itself, increasing the likelihood of infectionof the insertion site. This residue may also make the catheter stickierand more difficult to handle for medical attendants.

[0009] For these reasons, a need exists for an improved dialysiscatheter retainer which may be used on patients where the catheterremains in place over an extended period of time.

SUMMARY OF THE INVENTION

[0010] In accordance with one aspect of the present invention, aretainer for releasably securing a portion of a medical article, such asa dialysis catheter, to a patient includes an adhesive spot located uponthe inner surface of a channel of the retainer. The retainer has a coverand a base which are coupled by a flexible hinge, such that the covermay be opened. The channel is formed by a groove disposed on the base ofthe retainer and a corresponding groove disposed on the cover of theretainer. When the cover is closed over the base of the retainer, thetwo grooves form a channel through the retainer. The adhesive spotdesirably has a tacky surface which frictionally inhibits any lateral orlongitudinal motion of the retained portion of the medical articlethrough the channel of the retainer. Furthermore, the transversethickness of the adhesive spot is such that the adhesive spot pressesagainst the retained portion of the medical article when the cover is inthe closed position and the medical article passes through the channelof the retainer, thereby inhibiting transverse motion of the retainedportion of the medical article.

[0011] In accordance with another aspect of the present invention, aretainer for releasably securing a portion of a medical article isconstructed with a compressible member within the channel of theretainer. This allows the retainer to accommodate medical articles withdifferent transverse heights within the same retainer. When a retainerof thicker transverse dimension than that of the channel opening isclosed within the retainer, the medical article will be pressed into thecompressible member, squeezing it transversely. This compression of themember will result in a more secure fit between the channel of theretainer and the medical article.

[0012] In accordance with a further aspect of the present invention, aretaining member is provided within the channel of a retainer forreleasably securing a portion of a branched medical article. Theretaining member is disposed within this channel such that when thecover of the retainer is in the closed position, the retaining memberseparates one end of the channel into two separate passages. In thisway, branching medical articles, such as dialysis catheters, can beinhibited from longitudinal movement because the retaining member liesbetween the two distal branches of the medical article.

[0013] In accordance with an additional aspect of the present invention,a latching mechanism for use with a retainer comprises a keeper disposedupon the cover and a latch disposed upon the base of the retainer. Thekeeper comprises at least one member capable of interengaging with atleast a portion of the latch on the base, and the latch comprises atleast a recess which accepts at least a portion of the member of thekeeper when the cover is in the closed position. The keeper furthercomprises an operator lever which may be actuated by the fingertip of amedical attendant by pressing downwardly upon it to deflect the bar ofthe keeper inward, disengaging the member from the recess of the latch.

[0014] It is understood that the retainer can take various modes, andnot all modes need include all of the aspects noted above. Thus, forexample, those skilled in the art will recognize that the invention maybe embodied or carried out in a manner that utilizes one of or a groupof the noted aspects and features of the invention, without necessarilyusing all such aspects and features.

[0015] In a preferred mode of the present invention, a retainer forsecuring a medical article to a patient comprises a base and cover whichform a channel, as described above, and a compressible adhesive spot isdisposed on the surface of this channel. In this way, the retainerinhibits motion of the retained portion of the medical article in thelongitudinal, lateral, and transverse directions and also allows theretainer to accommodate medical articles of varying transverse heights.A latching mechanism is disposed in part on the base and in part on thecover of the retainer so as to selectively secure the retainer in theclosed position.

[0016] In another preferred mode of the present invention, an anchoringsystem for a medical article is created using a retainer as describedabove with an anchor pad. The anchor pad provides an adhesive lowersurface for attaching to the skin of a patient, and the upper surface isattached to the retainer. The retainer preferably has a substantiallydisc shaped base which provides a stable surface with which to attachthe retainer to the upper surface of the anchor pad. This arrangementallows the medical article to be anchored to the skin of the patient,and also allows the selective release of the medical article from theretainer so as to facilitate changing the anchoring system withoutremoving the medical article from the patient.

[0017] In a further preferred mode of the present invention, acatheterization system comprises a catheter including a branching siteand an anchoring system as described for securing this catheter to apatient. The catheter is one which includes a single elongated bodyextending proximally from one side of the branching site and at leasttwo elongated bodies extending distally from the other side of thebranching site, thereby forming a “Y” shaped junction, or “Y-site.”

[0018] In another preferred mode of the present invention, the catheterincludes a winged portion which is disposed proximally of the Y-site ofthe catheter. This winged portion is wider than the width of the channelof the retainer. By placing the winged portion immediately proximal ofthe retainer, the winged portion will be inhibited from migratingdistally into the channel by its width, providing additional securementto the catheter.

[0019] In an additional preferred aspect of the present invention, themedical article is secured axially with respect to the patient by use ofa device as described above. The medical article is placed within thegroove of the base of the retainer, and then the cover is closed overthe medical article. In this way the medical article is held within theretainer of the anchoring system. The anchoring system may then beadhered to the skin of the patient at a suitable location, therebyinhibiting any motion between the patient and the medical article.

[0020] Further aspects, features and advantages of this invention willbecome apparent from the detailed description of the preferredembodiment which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above mentioned and other features of the invention will nowbe described with reference to the drawings of a preferred embodiment ofthe present anchoring system. The illustrated embodiment of theanchoring system is intended to illustrate, but not to limit theinvention. The drawings contain the following figures:

[0022]FIG. 1 illustrates an anchoring system in accordance with apreferred embodiment of the present invention in perspective view withthe cover open.

[0023]FIG. 2 illustrates a perspective view of the anchoring system ofFIG. 1 with the cover closed.

[0024]FIG. 3 illustrates an exploded perspective view of the anchoringsystem of FIG. 1.

[0025]FIG. 4 illustrates an enlarged perspective view of the retainer ofthe anchoring system of FIG. 1.

[0026]FIG. 5 illustrates a top plan view of the retainer of FIG. 4.

[0027]FIG. 6 illustrates a proximal side view of the retainer of FIG. 4.

[0028]FIG. 7 illustrates a right side view of the retainer of FIG. 4.

[0029]FIG. 8 illustrates a perspective view of the retainer of FIG. 4with the cover in the closed position.

[0030]FIG. 9 illustrates a perspective view of the retainer of FIG. 8with the cover in the open position.

[0031]FIG. 10 illustrates a cross sectional view of the retainer takenalong line 10-10 of FIG. 5 with the cover in the open position.

[0032]FIG. 11 illustrates a cross sectional view of the retainer of FIG.10 with the cover in the closed position.

[0033]FIG. 12 illustrates a cross sectional view of the retainer of FIG.10 with the latch released and the cover in the closed position.

[0034]FIG. 13 illustrates a cross sectional view of the retainer of FIG.10 with the cover unlatched and slightly open.

[0035]FIG. 14 illustrates a perspective view of the retainer of FIG. 4with an exemplary dialysis catheter shown in position upon the retainer.

[0036]FIG. 15 illustrates a perspective view of the retainer of FIG. 14with the cover in the closed position.

[0037]FIG. 16 illustrates a perspective view of the anchoring system ofFIG. 1 in use upon a patient.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0038] The following description and examples illustrate a preferredembodiment of the present anchoring system in detail which is disclosedin the context of use with an exemplary dialysis catheter. Theprinciples of the present invention, however, are not limited todialysis catheters. It will be understood by those of skill in the artin view of the present disclosure that the anchoring system describedcan be used with other types of medical articles, including, but notlimited to: other catheters, fluid delivery tubes, and electrical wires.One skilled in the art may also find additional applications for thedevices and systems disclosed herein. Thus, the illustration anddescription of the anchoring system in connection with a dialysiscatheter is merely exemplary of one possible application of theanchoring system.

[0039] To assist in the description of these components of the anchoringsystem (see FIG. 1), the following coordinate terms are used. A“longitudinal axis” is generally parallel to the section of the catheterretained by the anchoring system 10. A “lateral axis” is normal to thelongitudinal axis and is generally parallel to the plane of an anchorpad 12, as seen in FIG. 1. A “transverse axis” extends normal to boththe longitudinal and lateral axes. In addition, as used herein, “thelongitudinal direction” refers to a direction substantially parallel tothe longitudinal axis; “the lateral direction” refers to a directionsubstantially parallel to the lateral axis; and “the transversedirection” refers to a direction substantially parallel to thetransverse axis. The term “axial” as used herein refers to the axis ofthe catheter, and therefore is substantially synonymous with the term“longitudinal” as used herein. Also, the terms “proximal” and “distal”,which are used to describe the present anchoring system, are usedconsistently with the description of the exemplary applications. Thus,proximal and distal are used in reference to the center of the patient'sbody. The terms “upper,” “lower,” “top,” “bottom,” and the like, whichalso are used to describe the present anchoring system, are used inreference to the illustrated orientation of the embodiment. A detaileddescription of a preferred embodiment of the anchoring system, and itsassociated method of use, now follows.

[0040] Overview

[0041] As shown in FIG. 1, the described embodiment comprises ananchoring system 10 in two main components: the anchor pad 12 and aretainer 20. As noted above, the anchoring system can form a componentof a catheterization system that also includes one or more medicalarticles (e.g., a dialysis catheter).

[0042] The retainer 20 is mounted upon the anchor pad 12 and the anchorpad is secured to the skin of the patient, generally by an adhesivedisposed upon the bottom surface of the pad. The retainer receives themedical article and secures it in position. The retainer itselfcomprises several sub-components, including a base, a cover, at leastone adhesive spot, and one or more retaining members. The releasableengagement of the medical article is achieved, at least in part, bycooperation between the adhesive spot, the base and the cover. Becausethe cover may be opened after the medical article is secured, it ispossible for the medical article to be removed from the anchoring systemfor any necessary purpose, such as to replace the anchoring system or tofacilitate moving the patient. This removal of the medical article fromthe anchoring system can be accomplished without removing the anchoringsystem from the patient if desired.

[0043] The medical article is held in position through a combination oflateral and transverse pressure along the secured portion of the medicalarticle within a channel of the retainer. In the illustrated embodiment,the channel is formed between grooves disposed upon the base and thecover of the retainer. Lateral pressure is provided between the walls ofthe grooves and the sides of the Y-site of the retained medical article,and transverse pressure is provided by the bottom and upper portions ofthe channel and the adhesive spot. When the cover is closed and securedinto the closed position by the latching mechanism, these forces inhibitthe tube from moving substantially in either the lateral or transversedirections. Longitudinal motion of the tube is inhibited by the frictionof the adhesive spot against the catheter, as well as by the taperedshape of the channel itself.

[0044] Furthermore, the embodiment described provides a universalfeature such that the anchoring system can be used to receive and securea variety of sizes of medical articles. Because the securing forces areprovided in part by a compressible adhesive spot, a variety of cathetersof varying transverse heights may be accommodated. Furthermore, thefrictional nature of the adhesive spot allows for the channel to provideadditional shear forces to retain the catheter within the channel.

[0045] The anchoring system also desirably releasably engages thecatheter. This allows the anchoring system to be disengaged from thecatheter without removing the catheter for any of a variety of knownpurposes. For instance, the healthcare provider may wish to remove theanchoring system in order to change the anchor or clean the insertionsite without removing the catheter from the patient. In situations wherethe catheter is in position in the patient for an extended period oftime, it is advantageous to periodically change the anchor to maintainthe best positional securement of the catheter. For these purposes, itis desirable that the disengagement of the catheter from the anchoringsystem can be accomplished without removing the catheter from thepatient.

[0046] Before describing the present anchoring system in detail, a briefdescription of a dialysis catheter is provided to assist the reader'sunderstanding of the exemplary embodiment that follows. As bestunderstood from FIG. 14, the catheter 8 includes a proximal tip whichwill be inserted into a large vein in the chest cavity, such as the venacava. The interior of the catheter has two independent lumens, each ofwhich has an opening near the proximal tip. The catheter includes aY-site 112 where the two lumens separate and above which each has aseparate branch of the catheter. The lumens of these branches assumeeither a coaxial or side-by-side arrangement on the proximal side of theY-site 112 to form a main catheter body 118. On the distal side of theY-site 112, a webbing may extend between the two branches 114, 116 at apoint next to the Y-site 112. The Y-site 112 may also include agenerally triangular plastic housing within which the branching of thelumens takes place.

[0047] With reference now to FIGS. 1 to 3, the anchoring system 10includes an anchor pad 12 and a retainer 20. The anchor pad 12 securesthe retainer 20 to a patient's skin. The anchor pad 12 has a loweradhesive surface 16 which adheres to the skin of a patient and aroughened upper surface 14 which supports a retainer 20. The retainer 20is configured to accept and retain a section of a dialysis catheterwithin the anchoring system 10. In the illustrated embodiment, theretainer comprises a base 22 and a cover 24. The cover 24 is releasablysecured to the base 22 and moveable between open and closed positions.

[0048] Anchor Pad

[0049] FIGS. 1 to 3 illustrate an anchor pad 12 which desirablycomprises a laminate structure with an upper foam layer (e.g.,closed-cell polyethylene foam), and a lower adhesive layer. The loweradhesive layer constitutes the lower surface 16 of the anchor pad 12.The lower surface 16 desirably is a medical-grade adhesive and can beeither diaphoretic or nondiaphoretic, depending upon the particularapplication. Such foam with an adhesive layer is available commerciallyfrom Avery Dennison of Painsville, Ohio. Although not illustrated, itwill be understood that the anchor pad 12 can include suture holes inaddition to the adhesive layer to further secure the anchor pad 12 tothe patient's skin.

[0050] In an alternative embodiment, a hydrocolloid adhesive mayadvantageously be used upon the anchor pad 12 for attaching the anchorpad to the skin of the patient. The hydrocolloid adhesive has less of atendency to excoriate the skin of a patient when removed. This may beparticularly important for patients whose skin is more sensitive orfragile, such as those with a collagen deficiency, common to dialysispatients.

[0051] As shown in FIG. 3, a surface of the upper foam layer constitutesan upper surface 14 of the anchor pad 12 (see FIG. 2). The upper surface14 can be roughened by corona-treating the foam with a low electriccharge. The roughened or porous upper surface 14 can improve the qualityof the adhesive joint (which is described below) between the base 22 andthe anchor pad 12. In the alternative, the flexible anchor pad 12 cancomprise a medical-grade adhesive lower layer, an inner foam layer andan upper paper or other woven or nonwoven cloth layer.

[0052] A removable paper or plastic release liner 18 desirably coversthe adhesive lower surface 16 before use. The liner 18 preferablyresists tearing and desirably is divided into a plurality of pieces toease attachment of the pad to a patient's skin. In the illustratedembodiment, the liner 18 is split along a center line 19 of the flexibleanchor pad 12 in order to expose only half of the adhesive lower surface16 at one time.

[0053] The liner 18 length, as measured in the lateral direction,extends beyond the center line 19 of the anchor pad 12 and is foldedover, or back onto the liner 18. This folded over portion defines a pulltab 17 to facilitate removal of the liner 18 from the adhesive lowersurface 16. A medical attendant uses the pull tab 17 by grasping andpulling on it so that the liner 18 is separated from the lower surface16. The pull tab 17 overcomes any requirement that the medical attendantpick at a corner edge or other segment of the liner 18 in order toseparate the liner 18 from the adhesive layer. The pull tab 17 of coursecan be designed in a variety of configurations. For example, the pulltab 17 can need not be located along a center line 19 of the anchor pad12; rather, the pull tab 17 can be located along any line of the anchorpad 12 in order to ease the application of the anchor pad 12 onto thepatient's skin at a specific site. For example, an area of a patient'sskin with an abrupt bend, such as at a joint, can require that the pulltab 17 be aligned toward one of the lateral ends of the anchor pad 12rather than along the center line 19.

[0054] As best seen in FIG. 3, the anchor pad 12 also desirably includesa pair of opposing concave sections 13, 15 that narrows the center ofthe anchor pad 12 proximate to the base 22. As a result, the lateralsides of the anchor pad 12 have more contact area which provides greaterstability and adhesion to a patient's skin.

[0055] Retainer

[0056] With reference now to FIGS. 4 to 9, the retainer 20 includes arigid structure principally formed by the base 22 and the cover 24 (seeFIG. 4). In the illustrated embodiment, the base 22 and cover 24 areintegrally formed to comprise a unitary retainer 20. This can beaccomplished in any of a variety of ways well known to those skilled inthe art. For instance, the entire retainer 20 can be injection molded inorder to reduce fabrication costs.

[0057] Additionally, as will be apparent from the below description,several features of the retainer, such as the latch 80 and hinge 40, aredesirably flexible. Suitable rigid but flexible materials include forexample without limitation: plastics, polymers or composites such aspolypropylene, polyethylene, polycarbonate, polyvinylchloride,acrylonitrile butadiene styrene, nylon, olefin, acrylic, polyester, aswell as moldable silicon, thermoplastic urethane, thermoplasticelastomers, thermoset plastics and the like. The illustrated retainer 20preferably is formed by injection molding using polyethylene orpolypropylene material. However, other materials can be utilized, andthe retainer 20 can comprise a non-unitary base 22 and cover 24.

[0058] With reference to FIG. 4, a base 22 in the illustrated embodimentcomprises an elongated body of a generally parallelepiped shape. Thebase 22, however, can be configured in a wide variety of shapes as well,such as circular, square, triangular or the like in order to suit aparticular application. Furthermore, the lower surface of the base isdesirably substantially disc shaped. This provides a larger surface atthe bottom of the retainer for use in attaching the lower surface of thebase to the upper surface of the anchor pad. This disc shaped lowersurface improves the attachment between the retainer and anchor pad, andalso provides greater stability to the retainer upon the skin of thepatient.

[0059] It is advantageous for the longitudinal dimension of the base 22to be sufficiently long to provide stability to the catheter 8 along itslength. In this way, the longitudinal length of the retained catheterportion is sufficient to inhibit rocking of the catheter 8 relative tothe retainer 20 (i.e., to prevent the retainer 20 from acting as afulcrum for the catheter). Also, the lateral dimension of the base 22desirably allows the healthcare provider to easily and naturally gripthe base 22, and also provides space on which to locate a hinge 40 and aportion of the latch mechanism 80.

[0060] As shown in FIG. 4, the base 22 includes first and second sides26, 28. The first side 26 lies generally at one lateral end of the base22, and the second side 28 lies at an opposite lateral end of the base22.

[0061] A groove 30 is formed on the base 22 between the first side 26and the second side 28. In the illustrated embodiment, the groove 30 hasgenerally a curvilinear cross-sectional shape. As best seen in FIG. 5,the lower groove 30 is also varied in width (i.e., in the lateraldirection) along its longitudinal length. That is, in the illustratedembodiment, the side walls of the lower groove 30 diverge from eachother in a generally linear manner from one longitudinal side of theretainer 20 to the other longitudinal side of the retainer.

[0062] The base 22 of the retainer 20 is attached to the upper surface14 of the anchor pad 12. The base 22 desirably is secured to the uppersurface 14 by a solvent bond adhesive, such as cyanoacrylate or otherbonding material. One such adhesive is available commercially as PartNo. 4693 from the Minnesota Mining and Manufacturing Company (3M).

[0063] As also seen in FIG. 4, the cover 24 has an elongate shape whichdesirably is substantially coextensive with the planar size and shape ofthe base 22. However, the cover need not be precisely the same size orshape as the base 22. For instance, the cover 24 can be sized to extendbeyond any of the lateral, traverse, or longitudinal edge of the base22. The cover may also be sized so as to not extend to a particularlateral, traverse, or longitudinal edge of the base 22. The cover canalso include a skirt or flange that extends over and/or about the base22 or any portion thereof.

[0064] The cover 24 desirably has a sufficient size to cover the lowergroove 30 in the base (see FIG. 8) and to accommodate a portion of thelatch mechanism 80 and the hinge 40 which operate between the base 22and the cover 24, as described below. The cover 24 also desirably is ofa dimension which provides for easy manipulation. For example, thecover's size easily accommodates the grasp of a medical attendant.

[0065] The cover 24 includes a first side 32 which lies generally at onelateral end of the cover 24 as shown in FIG. 4. The first side 32 of thecover therefore generally corresponds to the first side 26 of the base22. The cover 24 also has a second side 34. The second side 34 liesgenerally toward a lateral end of the cover 24, opposite of the firstend, and corresponds generally to the second side 28 of the base 22.

[0066] An upper groove 36 is formed on an inner side of the cover 24between the first and second sides 32, 34 of the cover 24 andcorresponds generally to the lower groove 30 formed in the base 22 (seeFIGS. 5 and 6). The width of the upper groove 36 is also varied in thelateral direction along its longitudinal length. That is, in theillustrated embodiment, the side walls of the upper groove 36 divergefrom each other in a generally linear manner from one longitudinal endof the cover 24 to the other longitudinal end as shown in FIG. 5.

[0067] The cover 24 is flexibly coupled to the base 22 by way of aflexible coupling or hinge 40. The coupling 40 desirably comprises aflexible band 42 that can take any number of forms to mechanicallyconnect the cover 24 to the base 22 while permitting pivotal movement ofthe cover 24 relative to the base 22 so as to enable engagement ordisengagement of these parts, as described below. In the illustratedembodiment, the band 42 is formed of flexible material, desirably of thesame material from which the base 22 and cover 24 are comprised.Advantageously, the hinge 40 is integrally molded with the base 22 andthe cover 24 to form a unitary member, as noted above. The hinge 40 islocated at an outer edge of the base 22 and the cover 24; however, thehinge 40 need not be laterally located at an extreme end of the base 22or cover 24.

[0068] As best understood from FIG. 5, the width of the hinge 40, asmeasured in the longitudinal direction, is desirably less than that ofeither the base 22 or the cover 24 to allow some leeway or play whenengaging or disengaging the cover 24 to the base 22. That is, this shapeallows the hinge 40 to twist to some degree to compensate for somemanufacturing tolerances; however, the hinge 40 can have at least aslarge of a longitudinal dimension as the base 22 and the cover 24.

[0069] The hinge 40 is desirably integrally formed along a commoncorresponding exterior surface of the cover 24 and base 22. In theillustrated embodiment the hinge 40 generally has a U-shape when thecover 24 is closed, and extends from both the base 22 and the cover 24in the lateral direction to the side of the retainer 20. A gap,corresponding to a transverse height of the hinge, exists between thebase 22 and cover 24. This gap, however, can be reduced or eliminatedfrom the retainer for some applications by using a different hingedesign.

[0070] The hinge 40 enables the cover 24 to move between the openposition and the closed positions. The open position, as illustrated inFIG. 4, is characterized by exposing the grooves 30, 36 in the base 22and the cover 24 in the transverse direction and thereby spacing apartthe base 22 and the cover 24. When in the open position, the retainer 20is capable of receiving a portion (e.g., the Y-site 112) of the dialysiscatheter 8. The closed position, as illustrated in FIG. 8, ischaracterized by the cover 24 lying in contact or near contact with thebase 22 so as to position the upper groove 36 above the lower groove 30.When in the closed position, the retainer 20 surrounds the receivedportion of the catheter.

[0071] The hinge 40 need not provide 180° of movement of the cover 24relative to the base 22 to establish the closed position and a fullyopen position, as illustrated by FIGS. 8 and 9. For instance, the hinge40 can permit a smaller degree of movement (e.g., 90°) between the base22 and the cover 24 while still providing enough space to transverselyinsert the catheter into the retainer 20.

[0072] The grooves 30, 36 formed in the base 22 and the cover 24 definea channel 60 when the retainer 20 is closed. The channel 60 is capableof receiving a portion or length of the catheter and is generallyconfigured to house, grip and secure the affected catheter portion. Thechannel 60 can have a variety of configurations, as discussed above inconnection with the grooves 30, 36, in order to accommodate a particularmedical article. In the illustrated embodiment, the channel 60 generallyhas circular cross-sectional shape at its proximal end 62 and agenerally oblong cross-sectional shape at its distal end 64 (although,in the illustrated embodiment, the distal end 64 is divided by a pair ofcooperating post, which will be described below). The channel smoothlytapers in cross-sectional size from its smaller proximal end 62 to itslarger distal end 64. The channel 60 consequently generally has atruncated V-shape, as best understood by inspecting the shapes of thegrooves 30, 36 in FIG. 5.

[0073] In the embodiment illustrated, the sides of the channel 60 aregenerally straight and diverge from each other. The walls of the channel60 (and, thus, the grooves of the cover and base), however, need not bestraight. This channel shape furthers retention of the catheter withinthe channel 60 to inhibit catheter movement through the channel, asdiscussed below.

[0074] Although the channel 60 can take the form of various shapesdepending upon its application (i.e., depending upon a shape of theretained portion of the medical article for which the retainer isdesigned to be used), the channel 60 does have a sufficient length inthe longitudinal direction to stabilize the catheter, rather than act asa fulcrum for the catheter, as mentioned above. That is, the retainerreceives a sufficient length of the catheter to inhibit movement of thecatheter in the lateral, longitudinal and transverse direction (i.e., toinhibit yaw, pitch and axial movement of the catheter), without kinkingthe catheter. Also, the wide-mouth shape (i.e., the large oval-shape) ofthe channel proximal opening eliminates an edge or surface over whichthe catheter could kink.

[0075] When the cover 24 is closed, a section of the catheter 8 iscaptured within the retainer 20 (as shown in FIG. 15). Thus, theretainer 20 at least restricts, if not prevents, lateral and transversemovement of the retained section of the catheter 8.

[0076] Additionally, as shown in FIG. 9, an adhesive spot 200 may alsobe advantageously disposed upon the inside of the cover within the uppergroove. This adhesive spot may take the form of a glue dot. Such gluedots are desirably formed of a material which exhibits high resistanceto shear and which can be peeled off of the catheter Y-site withoutleaving a residue. Such an adhesive is sold by All-Pak Inc. of NewBerlin, Wis. as part number GD-06 “Super High Tack Glue Dot.” Multipleglue dots may be used, or a single glue dot may be disposed on only oneside of the channel of the retainer.

[0077] The adhesive spot 200 is represented in all figures as a glue dotshown in hidden lines on both the surface of the cover groove 36 and thebase groove 30 (see FIG. 4). It is not necessary for multiple glue dotsto be used; a single glue dot disposed upon either the cover groove orbase groove may advantageously be used to provide greater frictional andtransverse forces between the retainer 20 and the catheter.

[0078] Furthermore, the adhesive spot 200 need not be a single point ofadhesive. In further preferred designs the adhesive spot may be a regioncomposed of an elastic and compressively deformable material suchKraton® polymer compounds. Such a compound includes Dynaflex® G2706available from GLS Corporation, as well as other thermoplasticelastomers or silicone or urethane epoxies.

[0079] This region also need not be round. In further preferred designs,a large region of the surface of the channel 60 may be covered with asuitable material, such as Kraton®. For instance, the entire surface ofthe lower groove 30 might be covered with a thin layer of adhesive toadvantageously provide additional traction and transverse bias betweenthe catheter and retainer.

[0080] Other means of producing an appropriate adhesive spot for usewith various preferred embodiments of the present invention includewithout limitation: treating a portion of the surface of the channelchemically or electrically to adjust its surface friction orcompressibility; spraying or spreading an adhesive coating onto aportion of the grooves of the retainer; attaching peel-off adhesivemembers to portions of the channel; injection molding regions ofadhesive or compressible material, such as Kraton®, to a portion of thesurface of the channel; or such other means as are known in the art.

[0081] Inhibiting movement of the catheter 8 in the longitudinaldirection when the catheter 8 is secured within the channel 60 is alsodesirably accomplished by one or more retention mechanisms thatassociate with the channel 60. With reference to FIGS. 5, 6 and 7, onesuch retention mechanism involves the shape of the channel 60 itself.The interaction between the truncated V-shape of the channel 60 and acorresponding shape of the catheter Y-site 112 inhibits proximallongitudinal movement.

[0082] As best understood from FIG. 14, the proximal end 62 of thechannel 60 is sized to receive only the main body 118 of the catheter 8.The distal end 64 of the channel 60 is sized to receive both branches114, 116 of the catheter at the distal side of the Y-site 112. Andbetween its distal and proximal ends 64, 62, the channel 60 isconfigured to receive the catheter Y-site 112.

[0083] In the illustrated embodiment, each side of the channel 60 isangled so as to provide a narrower channel on the proximal end than onthe distal end. This is accomplished by angling the sides 66, 68 of thechannel so that they converge toward the proximal end of the retainer.While the illustrated embodiment uses the same angle for each side ofthe channel, it may be advantageous for some applications to create thechannel with different angles for the first side and second side of thechannel.

[0084] The sides 66, 68 of the channel 60 desirably vary in a taperingor linear manner (although they may include a convex section as notedabove). An angle of divergence between the first and second sides 66, 68of the channel 60 is desirably between about 10° and about 70°, and morepreferably is between about 30° and about 45°, and generally matches theangle at which the two branches 114, 116 of the catheter intersect, asseen in FIG. 14.

[0085] Because the catheter Y-site 112 is larger in cross-section thanits main body 118, the Y-site 112 usually cannot be pulled proximallythrough the smaller proximal end 62 of the retainer channel 60. Theshape of the channel 60 thus inhibits longitudinal movement of thecatheter in the proximal direction.

[0086] Variations on the channel's shape of course are also possible, asnoted above. For instance, the second side 68 of the channel 60 can varyfrom the first side 66 in a curvilinear manner and/or can include agouge, protrusion or similar geometric abnormality so as to cooperatewith or impinge upon a corresponding portion of the received catheterlength. Also, there is no requirement that the sides of the channel besymmetrical to one another. Either the first 66 or second 68 side, orboth sides, can vary in distance relative to the axis of the receivedcatheter length so as to inhibit longitudinal movement of the retainedsection of the catheter 8. The channel, however, can have a straight oruniform cross-sectional shape where the retainer includes at leastanother mode of the retention mechanism.

[0087] The interaction between the surface of the retainer channel 60and the catheter Y-site 112 also creates friction to inhibitlongitudinal movement through the channel 60. The degree of interferencebetween the catheter 8 and the retainer 20, however, cannot be so greatas to significantly occlude the catheter 8.

[0088] The adhesive spot 200 forms an additional retention mechanism.When the cover is moved into the closed position, the glue dot or otheradhesive spot will be captured between the inner surface of the coverand the upper surface of the Y-site of the dialysis catheter or othermedical article. Once pressed between the cover and the catheter, theadhesive spot will tend to inhibit any shear motion between the twosurfaces which it contacts. In this way, the adhesive resists bothlongitudinal and lateral motion of the catheter within the retainer.

[0089] As shown in FIG. 9, a retaining structure 73, which protrudesinto the channel 60, can also be used to inhibit axial movement of thecatheter. The retaining structure 73 forms an upstanding membertransversely positioned relative to the anchor pad 12. The retainingstructure 73 is arranged to lie between the branches at the catheterY-site 112 retained by the retainer 20 so as to inhibit axial movementof the catheter 60 in the distal direction. Thus, in the illustratedembodiment, the combination of the tapering channel shape and theretaining structure 73 inhibits axial movement of the retained sectionof the catheter 8 in both the proximal and distal directions.

[0090] The retaining structure 73 desirably has a sufficient height toinhibit axial movement of the catheter 8 in the distal direction. Forthis purpose, the retaining structure 73 has a height, in the transversedirection, of at least about 25% of the height of the channel 60 at thelocation at which the structure is positioned. In the presentapplication, the retaining structure desirably extends across channel60.

[0091] In the illustrated embodiment, the retaining structure 73 isformed by a base post 74 and a cover post 78. The base post 74 desirablyis integrally formed with the base 22, and is located in the channel 60toward the distal end 64 of the channel 60. The cover post 78 isintegrally formed with the cover 24 also at the distal end 64 of thechannel 60. Although in the illustrated embodiment, the base post 74 andcover post 78 lie within the channel 60, the posts 74, 78 can be locatedoutside the distal end 64 of the channel 60.

[0092] In one mode, the base post 74 is sized to extend to a positionwhere its upper end lies near or contacts the webbing of the catheter 8(see FIG. 14) that extends between the Y-site branches 114, 116. In theillustrated embodiment, the upper end of the post 74 lies generally evenwith the upper surface of the first and second sides 26, 28 of the base20, as best seen in FIG. 6. The cover post 78 similarly extends to apoint which is generally flush with a plane defined by the innersurfaces of the cover first and second sides 32, 34 that lie adjacent tothe base 22.

[0093] As best seen in FIG. 6, the lateral position of the post 74within the channel 60 corresponds with the merge point between theinflation lumen branch 114 and the discharge lumen branch 116 of theDialysis catheter 8. The post 74 divides the channel 60 at the channel'sdistal end 64.

[0094] The cover post 78 is configured and arranged on the cover 24 in amanner similar to that described above in connection with the post 74 onthe base 22. In the illustrated embodiment, the post 78 thus generallyopposes the base post 74. By this particular design, as understood fromFIG. 5, the combination of the posts 74, 78 and the channel 60 define agenerally Y-shaped recess between the channel's proximal and distal ends62, 64.

[0095] In the illustrated embodiment, the transverse height of the coverpost 78 is less than that of the base post 74. The posts 74, 78,however, can have equal heights or the cover post 78 can be longer thanthe base post 74. Together though, as best seen in FIG. 11, the posts74, 78 desirably span the channel 60 in the transverse direction, exceptfor a small gap formed at their interface. This gap can be slightly lessthan a thickness of the catheter webbing between the Y-site branches114, 116, for the reasons described below, and corresponds to the gapprovided by the hinge 40 when the cover 24 is closed.

[0096] The posts 74, 78 thus extend between these two branches 114, 116of the catheter 8 when the catheter Y-site 112 is positioned within thechannel 60. Together the posts 74, 78 can act as a stop againstlongitudinal movement of the catheter 8 in the distal direction. Thatis, longitudinal movement in the distal direction causes the catheterY-site 112 to contact the posts 74, 78. The posts 74, 78, being of rigidconstruction, prevent further longitudinal movement.

[0097] Although the posts 74, 78 can have a variety of cross-sectionalshapes, the posts 74, 78 desirably have a generally triangularcross-sectional shape in the present application so as to correspond tothe space between the two catheter branches 114, 116 at the Y-site 112.The proximal edge of the posts, however, advantageously is rounded toeliminate sharp contact between the catheter 8 and the retainer 20 atthis location.

[0098] The posts 74, 78 can also include interengaging elements tointerlock the posts 74, 78 in the transverse direction and prevent thecatheter 8 from being pulled through the gap between their ends. In theillustrated embodiment, a pin or projection 81 and a correspondingreceptacle 79 are arranged between the interfacing ends of the posts 74,78. As best seen in FIG. 9, the receptacle 79 is formed at thetransverse end of the base post 74, extending into the post 74 in atransverse direction from an interface surface of the post 74. Theprojection 81 extends from an end of the cover post 78 in a directionparallel to a transverse axis of the post 78. The projection 81 isconfigured to fit within the receptacle 79. When the cover 24 is closed,the pin 81 extends into the receptacle 79 to interlock together theposts 74, 78.

[0099] Another possible retention mechanism to inhibit axial movement ofthe catheter 8 relative to the retainer 20 involves protuberances thatare arranged to cooperate with one another when the cover 24 is closed.For instance, in one mode, the cooperating posts 74, 78 can be arrangedto capture a structural portion of the catheter (e.g., the catheterwebbing) between them without substantially occluding an inner lumen ofthe catheter 8. In another mode, the projection 81 can be employedwithout the receptacle 79 to simply pin a portion of the catheter (e.g.,its webbing) against a surface of the retainer 20. For instance, theprojection 81 can extend from a portion of either the base 22 or thecover 24 and cooperate with a corresponding surface (be it a post,platform or channel surface) that opposes the projection 81 when thecover is closed. The projection 81 would protrude into the portion ofthe catheter and pin it against the corresponding surface.

[0100] Alternatively, the projection 81 can be used with the receptacle79 to capture a section of the catheter. When the cover 24 is closed,the projection 81 could force a portion of the catheter body 8 into thereceptacle 79 to capture a structural portion of the catheter 8 betweenthese components without occluding an inner lumen of the catheter. Thisengagement of the retainer 20 with the catheter body 8 would inhibitaxial catheter movement relative to the retainer 20.

[0101] Latch

[0102] To firmly hold the affected catheter portion within the channel,the base 22 and the cover 24 include interengaging structure to couplethem together in the closed position. In the illustrated embodiment, asbest seen in FIGS. 10 to 13, a latch mechanism 80 is used to secure thecover 22 to the base 24. The latch mechanism 80 comprises at least onemoveable keeper 88 and at least one latch 90. The keeper 88 is arrangedon the cover 24 while the latch 90 is arranged on the base 22; however,these components can be flip-flopped on the base and the cover.

[0103] As best seen in FIG. 10, each keeper 88 includes a bar 92extending toward the base 22 from the second side 34 of the cover 24.Two tangs 94 are formed at a lower end 96 of the bar 92. Desirably, thelower end 96 of the tangs 94 are relatively blunt and smooth to preventthem from puncturing the gloves or skin of a healthcare provider orcatching on other materials. An operator lever 98 extends to the side ofthe bar 92 and includes an enlarged platform or ear 100 at its outerend. The operator lever is angled upwardly from the bar when the coveris in the closed position. In this way, downward force upon the operatorlever produces a component which causes the bar to deflect inwardly,allowing the tang to disengage from the latch. The entire keeper 88desirably is formed with the cover 24 to form a unitary piece.

[0104] The latch 90 includes a receptacle 104 that receives the bar 92and the tangs 94. The latch receptacle 104 includes inner notches 106into which the tangs 94 snap when the cover 24 is in the closedposition; however, the tangs can be arranged in the receptacle and thenotches be positioned on the bar to accomplish the same effect. Thelatch 90 desirably is formed with the base 22 as a unitary piece.

[0105] In the illustrated embodiment there are two tangs 94 and twonotches 106 disposed symmetrically from front to back on the retainer.Each notch 106 is arranged to receive one of the keeper tangs 94 whenthe cover 24 is closed.

[0106] An entrance of the receptacle 104 includes chamber edges. Thechamfer edges slope inward toward the center of the receptacle 104 tocause the keeper bars 92 to bend inward when inserting the keepers 88into the latch receptacle 104.

[0107] As best understood from FIGS. 9 and 10, the second side 28 of thebase 22 also includes a slot 108 to receive a portion of the operatorlevers 98 and the bar 92 of the keepers 88 when the associated tangs 94are inserted into the receptacle 104.

[0108] In operation, the cover 24 can swing toward the closed position.The relatively thin strip of material forming the coupling allows thehinge 40 to bend when finger pressure is exerted on the cover 24 toclose it. The lower ends of the tangs 94 contact the chamfered edges 107of the latch receptacle 104 when the cover 24 nears its closed position.Continued pressure forces the bar 92 inward toward the channel to permitthe tangs 94 to pass through the receptacle. The slot 108 of thereceptacle 104 receives the operator lever 98 as the tangs 94 are pushedfurther into the receptacle 104. The tangs 94 snap into the notches 106,under the spring force provided by the deflected bar 92 when the cover22 sits atop the base 24. The interaction between the tangs 94 and thecorresponding surfaces of the notches 106 hold the cover 24 in thisposition. As best seen in FIG. 11, the operator lever 98 extends to thelateral side of the base 24 when the cover 24 is latched.

[0109] A medical attendant presses downward on the operator lever toopen the latch mechanism 80. A downwardly force applied to the angledouter surface exerts an inward force component which deflects the bar 92inward and releases the tangs 94 from the notches 106. The inherentspring force stored in the bent hinge band assists with providing atransverse force that moves the keeper 88 out of the receptacle 104. Themedical attendant can then open the cover 24 and expose the innergrooves 30, 36 of the base 22 and the cover 24.

[0110] The releasable engagement between the cover 24 and the base 22allows the same retainer 20 to be used even when opened and closedmultiple times. This allows for repeated attachment and reattachment ofthe catheter to the anchoring system 10. In addition, the hingedconnection connecting the cover 24 to the base 22 ensures that the cover24 will not be lost or misplaced when the catheter is detached from theanchoring system 10. The medical attendant wastes no time in searchingfor a cover, nor in orienting the cover prior to latching.

[0111] Variations

[0112] Additional securement of the medical article may be providedusing further techniques to those described above. These can include theuse of friction ridges and securement barbs within the channel of theretainer as will be described below.

[0113] Friction ridges may be located on the channel surface as afurther retention mechanism to inhibit axial movement of the catheter.These ridges are integrally formed with the base and the cover andproject into the channel. Such ridges may be used in addition to theretention mechanisms described above, as well as either with or withoutthe securement barbs described below.

[0114] The ridges are desirably of smooth solid construction; however,they can be of hollow construction. The ridges in the illustratedembodiment have generally triangular cross-sectional shapes and angletoward one end of the channel (e.g., the distal end). The ridges,however, can have other cross-sectional shapes which would interferewith axial movement of the catheter through the channel.

[0115] Each of the ridges desirably has a front wall or leading edgethat forms an angle of less than degrees as measured between the frontwall and the channel surface. The ridges slightly protrude into thechannel, desirably at a transverse distance of between 0.1 to 10 mm forthe given application. The ridges also lie generally normal to alongitudinal axis through the channel.

[0116] When so arranged, the friction ridges gently, but securely biteor press into an outer surface of the catheter Y-site. Such contact doesnot occlude or otherwise meaningfully impair fluid flow in the catheterlumens because of the compliant nature of the catheter body material andbecause of the degree to which the ridges bite into the catheter body.This degree of contact, however, coupled with the angular orientation ofthe ridges inhibits movement of the catheter, especially in a directionopposite of that in which the ridges are angled.

[0117] One or more securement barbs can also be used to retain thecatheter in the longitudinal direction. Each barb has a generallyconical shape with a blunt tip. The barb in the present applicationdesirably extends into the channel by an amount ranging between about0.1 mm and about 3 mm.

[0118] The retainer may advantageously include at least one set ofsecurement barbs, indicated collectively by reference numeral, the barbsbeing arranged within the channel to cooperate with one another. Thebarbs advantageously are arranged within the same general lateral plane(i.e., a plane defined by the lateral and transverse axes), and arespaced apart from one another. In addition, the barbs desirably arespaced on generally opposite surfaces of the channel in a staggeredarrangement. That is, the position of the barbs alternate between thecover surface and the base surface in the lateral direction. Theresulting overlapping pattern of the barbs securely holds the catheterwithout imparting torque to the catheter if pulled in a longitudinaldirection. In the illustrated embodiment, one barb is positioned on thecover surface and is generally equally distanced in the lateraldirection from the adjacent side of the channel and the adjacent side ofthe post. A pair of barbs is positioned on the base surface. These barbsare spaced apart from one another and the pair is symmetricallypositioned relative to a transverse axis that extends through the barbon the cover surface.

[0119] The retainer may also further comprise a second set of barbs inan additional preferred embodiment. These are arranged generally inaccordance with the above description; however, fewer number of barbs,as well as fewer sets, can also be used. In one particular embodiment,one set of barbs is placed between the posts 74, 78 and the first sides26, 32 of the cover 24 and the base 22, and the other set of barbs isplaced between the posts 74, 78 and the second sides 28, 34 of the cover24 and the base 22. The barbs of the first set are desirably angledtoward the distal end 64 of the channel 60 to inhibit movement of thecatheter's inflation lumen branch 114 in the proximal direction when thecatheter 8 is pulled proximally, as well as when the catheter 8discharge branch 116 is pulled distally. The barbs of the second set,however, are desirably angled toward the proximal end 62 of the channel60 to inhibit movement of the catheter 8 when the catheter is pulleddistally.

[0120] The anchoring system described herein is especially adapted toarrest axial movement of a catheter with a slippery coating, as well asto hold the catheter against the patient. For this purpose, theanchoring system utilizes one or more retention mechanisms. Theanchoring system accomplishes this without meaningfully impairing (i.e.,substantially occluding) the fluid flow through the catheter to a degreethat would create complications. As described, such retention mechanismsinvolve, among others, the shape of the channel that retains a sectionof the catheter, retaining structure either aligned with or positionedwithin the channel, one or more securement barbs or friction ridges thatbite into the catheter body without substantially occluding the catheterdrainage lumen, and cooperating members that come together to clamp ontoor pin down a portion of the catheter (e.g., a webbing formed betweenthe branches at the Dialysis catheter Y-site).

[0121] Operation

[0122] As illustrated in FIGS. 14 to 16, a medical attendant can securea dialysis catheter (or other medical article) to a patient using theabove-described anchoring system (or a readily apparent modificationthereof). The medical attendant first opens the retainer 20 to exposethe groove 30 on the base 22. Once opened, a catheter 8 can betransversely aligned over the groove 30. The catheter 8 can then beplaced into the channel 60. If the channel 60 is formed with a post 74(or another protuberance) for use with a Y-site, the first and secondbranches 114, 116 are aligned around the post 74 and the catheter Y-site112 is aligned to securely fit within the remaining groove confines.Once the catheter 8 is so aligned and placed into the groove 30, thecover 24 is closed and latched, in the manner described above. Theshapes of the grooves 30, 36 ensure that the channel supports thecatheter Y-site 112 on at least diametrically opposed sides thereofalong the entire retained length of the catheter Y-site, and places aportion of the catheter Y-site in contact with the adhesive spot 200.This not only enhances frictional contact between the retainer 20 andthe catheter 8, but it also prevents the catheter 8 from kinking orcrimping with the retainer 20 and thereby occluding one or more of thecatheter lumens.

[0123] In the illustrated embodiment, the posts 74, 78 come togetherwith the projection 81 inserting into the receptacle 79 when the coveris closed. The posts 74, 78 therefore are interlocked in this positionto form a stop on the distal side of the Y-site 112 that spans entirelyacross the channel's transverse length. Any securement barbs (ifpresent) also bite into the body of the catheter Y-site 112 to resistmovement of the catheter branches 114, 116 in a direction opposite ofthe direction in which they are angled.

[0124] Because most dialysis catheters are approximately the sametransverse height, a single size retainer with a single sized channelcan be used to secure most catheters. The material of the retainer isslightly flexible, which helps the retainer accommodate catheters whichmay include plastic hubs of larger thickness located at the Y-site.Furthermore, the adhesive spot 200 disposed upon the channel isdesirably compressible in the transverse direction such that a largercatheter will simply compress the adhesive spot further without changingthe operation of the retainer in any substantial manner.

[0125] If the catheter 8 is pulled in the proximal direction, thetapered shape of the channel 60 prevents the larger distal end of theY-site 112 from pulling through the retainer. And if the retaineremploys posts or projections that clamp onto or pin the catheter webbingwithin the channel, then this engagement between the retainer and thecatheter would further secure the catheter in place. If the catheter ispulled in the distal direction, the interlocked posts 74, 78 and actionof the adhesive spot inhibit this movement.

[0126] The retainer 20 thus inhibits longitudinal movement of thecatheter 8 relative to the retainer, even when used with a lubricatedcatheter. The holding effect provided by each of the retentionmechanisms, however, does not substantially occlude the lumens of thecatheter. The interaction of the protuberances (i.e., the posts and/orprojection) only affects the catheter webbing (or like structure) anddoes not bear against the catheter body. Likewise, the interactionbetween the shape of the channel and posts restricts movement of thecatheter in both axial directions, but does not crimp or kink thecatheter body when it is inserted within the channel and about theposts. And although the securement barbs bear against the catheter body,their limited bite does not significantly occlude or penetrate thecorresponding catheter lumen.

[0127] Similarly, the action of the adhesive spot 200 in all cases actsalong the surface of the Y-site of the catheter to inhibit longitudinaland lateral motion between the catheter and the retainer. Because thisforce is exerted at the Y-site and primarily in a direction parallel tothe surface of the catheter, the retention force provided by theadhesive spot does not tend to occlude the lumen of the catheter.

[0128] Additionally, many dialysis catheters in use include a wingedsection, traditionally used for attachment to other types of anchoringdevices. Additional securement may be provided to the catheter byplacing the catheter into the channel of the retainer of the presentinvention such that the winged section lies proximal of the retainer butflush against it. In this way, when the cover of the retainer is closedand secured, the width of the winged portion of the catheter willprevent it from being pulled into the channel of the retainer. Thisprovides a further inhibition to distal migration of the catheter uponthe patient.

[0129] The various embodiments of the anchoring systems described abovein accordance with the present invention thus provide a means to securea dialysis catheter or other medical article to a patient releasably.The catheter may be released from the anchor and the dressing changedwithout dislodging the catheter. The anchoring system inhibitslongitudinal, lateral, and transverse motion of the catheter upon thepatient once secured within the retainer.

[0130] Of course, it is to be understood that not necessarily all suchobjects or advantages may be achieved in accordance with any particularembodiment of the invention. Thus, for example, those skilled in the artwill recognize that the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught herein without necessarily achieving other objects oradvantages as may be taught or suggested herein.

[0131] Furthermore, the skilled artisan will recognize theinterchangeability of various features from different embodiments. Forexample, the shape of the groove may be designed to accommodate acatheter with a large Y-site by using an un-tapered channel whileretaining the latch and keeper design of the illustrated embodiment. Orthe adhesive spot could be removed from a particular design while stillmaking use of the retaining post to pin a portion of the catheter Y-sitein place. In addition to the variations described herein, other knownequivalents for each feature can be mixed and matched by one of ordinaryskill in this art to construct anchoring systems and retainers inaccordance with principles of the present invention.

[0132] Although this invention has been disclosed in the context ofcertain preferred embodiments and examples, it therefore will beunderstood by those skilled in the art that the present inventionextends beyond the specifically disclosed embodiments to otheralternative embodiments and/or uses of the invention and obviousmodifications and equivalents thereof. Thus, it is intended that thescope of the present invention herein disclosed should not be limited bythe particular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

What is claimed is:
 1. An anchoring system for a medical articlecomprising: a medical article having an elongated body and a branchingsite at which point the elongated body separates into two elongatedbodies; a retainer comprising a base, a cover and an adhesive spot, thecover being pivotally coupled to the base and movable between an openposition and a closed position, the cover and the base cooperating todefine a channel when the cover lies in the closed position and beingconfigured to receive at least the branching site of the medicalarticle, and the adhesive spot being disposed upon the channel such thatthe adhesive spot lies in contact with the retainer and the medicalarticle when the cover is in the closed position and inhibits motion ofthe medical article relative to the retainer, the retainer furthercomprising a latching mechanism to releasably secure the cover in theclosed position upon the base.
 2. The anchoring system of claim 1, theretainer further comprising at least one retainer member projecting intothe channel and arranged to engage a portion of the medical article toinhibit axial movement of the medical article through the channel. 3.The anchoring system of claim 1 wherein the medical article furthercomprises a winged portion disposed proximal of the branching site. 4.The anchoring system of claim 3 wherein the winged portion of themedical article is positioned proximal to the retainer such that whenthe cover is secured over the retained portion of the medical articlethe winged portion of the medical article is inhibited from movingdistally into the channel.
 5. The anchoring system of claim 1 whereinthe adhesive spot exerts a frictional force between the surface of themedical article and the surface of the channel which inhibits relativemotion between the medical article and the retainer.
 6. The anchoringsystem of claim 1 wherein the adhesive spot exerts a transverse forcebetween the surface of the channel and the medical article to bias theretained portion of the medical article against the channel of theretainer.
 7. A retainer for securing an elongated medical article,comprising: a base; a cover which is attached to the base, the base andcover being configurable to surround a portion of the elongated medicalarticle; and a latching mechanism operable between the base and thecover to releasably secure the cover to the base, the latching mechanismincluding a keeper and a latch, one of the keeper and the latch beingdisposed upon the base and the other of the keeper and the latch beingdisposed upon the cover, the keeper having at least one bar capable ofinterengaging with at least a portion of the latch, and the latch havinga receptacle which accepts at least a portion of the bar when the coverand base surround the portion of the elongated medical article, thekeeper also including an operator lever that can be actuated by thefingertip of a medical attendant to deflect the bar of the keeper towardthe hinge to disengage the bar from the receptacle of the latch in orderto release the latch from the keeper.
 8. A retainer for securing anelongated medical article having a branching site, the medical articlealso having a winged portion disposed proximal of the branching site,the retainer comprising: a base; a cover movably coupled to the base andhaving an open configuration and a closed configuration, the cover andthe base cooperating to define a channel in the closed configuration andbeing configured to receive at least a portion of the medical article,the channel being dimensioned such that when the winged portion of themedical article is positioned proximal to the retainer and the cover isin the closed configuration, the winged portion of the medical articleis inhibited from moving distally into the channel.
 9. The retainer ofclaim 8 further comprising an adhesive spot disposed upon the channelsuch that the adhesive spot lies in contact with the retainer and themedical article when the cover is in the closed configuration and theadhesive spot inhibits motion of the medical article relative to theretainer.
 10. The retainer of claim 8 further comprising a latchingmechanism to releasably secure the cover in the closed configuration.11. A method of releaseably anchoring an elongated medical articleincluding a branching site onto a patient which permits the medicalarticle to be retained in the same position relative to the patient,comprising: providing an anchoring device which provides an adhesivelower surface, and a retainer comprising a base, a cover, and acompressible member, the base further comprising at least a groove, andthe base and the cover together forming a channel when the cover issecured in position over at least a portion of the base; inserting atleast the branching site of the medical article into the groove;positioning the cover over at least a portion of the groove; securingthe cover in a position overlying the covered portion of the groove topress a retained portion of the medical article against the compressiblemember to provide adhesion between the compressible member and theretained portion of the medical article; and securing the anchoringdevice to the skin of the patient via the adhesive lower surface of theanchoring device.
 12. A method of releaseably anchoring an elongatedmedical article including a branching site onto a patient which permitsthe medical article to be retained in the same position relative to thepatient, comprising: providing an anchoring device which provides anadhesive lower surface, and a retainer comprising a base, a cover, and acompressible member, the base further comprising at least a groove, andthe base and the cover together forming a channel when the cover issecured in position over at least a portion of the base; inserting atleast the branching site of the medical article into the groove;positioning the cover over at least a portion of the groove; securingthe cover in a position overlying the covered portion of the groove topress a retained portion of the medical article between the compressiblemember and a side of the channel; and securing the anchoring device tothe skin of the patient via the adhesive lower surface of the anchoringdevice.